Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation
Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Failure; Mesenchymal Stem Cells
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Sun Yat-sen University Official(s) and/or principal investigator(s): Zhi-liang Gao, Dr, Study Director, Affiliation: Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China
Summary
The study aimed to investigate the short-term efficacy and long-term prognosis of liver
failure patients caused by hepatitis B after single transplantation with autologous marrow
mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were
recruited and received the same medical treatments, among whom some patients underwent
single transplantation with autologous MMSCs and other patients with matched age, gender and
biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL),
prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group.
A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs
suspension were slowly transfused into the liver through the proper hepatic artery by
interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in
translation group were compared with those in control group. In 3 ~ 48 months of follow-up,
differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and
mortality between two groups were compared.
Clinical Details
Official title: Therapeutic Effects Including Short-term Changes And Long-term Outcomes of Liver Failure Patients Caused by Chronic Hepatitis B After Single Transplantation With Autologous Bone Marrow Mesenchymal Stem Cells.
Study design: Observational Model: Case Control, Time Perspective: Retrospective
Primary outcome: Short-term therapeutic effects of transplantation.
Secondary outcome: Long-term outcomes of transplantation.
Detailed description:
A total of 527 patients with chronic hepatitis B induced liver failure were recruited from
May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver
failure were based on previously described criteria. All patients received the same medical
treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene
phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained
before study. Among these patients, 53 received transplantation with autologous MMSCs. The
day of surgery served as the first day of observation. And 105 patients with matched age,
gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.
Eligibility
Minimum age: 15 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Liver failure
Exclusion Criteria:
- HBV negative
Locations and Contacts
The Third Affiliated Hospital Of Sun Yat-sen University, Guangzhou, Guangdong 510630, China
Additional Information
Starting date: May 2005
Last updated: December 6, 2010
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